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Completed

NCT Number: NCT01015859

Spontaneous Atrioventricular Conduction Preservation

The aims of this study are to assess the clinical benefits resulting from SafeR by comparison with standard dual chamber programming (DDD) with a long atrioventricular (AV) delay.

The benefits will be assessed by comparing the percentage of ventricular pacing, the incidence of atrial arrhythmias, and the evolution of the hemodynamic status as observed through echo parameter and atrial natriuretic peptide/brain natriuretic peptide (ANP/BNP) measurements.

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Key information

Conditions

Patients With Pacemaker With Conduction Problems Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Grey Nuns Hospital, Edmonton, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient who fulfils one or more of the official guidelines to be implanted with a dual-chamber pacemaker (primo-implantation3) may be included in the study.

Exclusion criteria

The patients presenting with one or more of the following characteristics cannot be included:

Permanent complete AV block

  • Permanent atrial and/or ventricular arrhythmias
  • already implanted with a cardioverter-defibrillator (ICD)
  • Likely to have a cardiac surgery in the next six months, mainly for:
  • severe coronary artery disease
  • severe valvular disease
  • AV node ablation
  • Refuses to sign an consent form after having received the appropriate information
  • Refuses to co-operate
  • Not able to understand the study objectives and protocol
  • Not available for scheduled follow-up
  • With a life expectancy less than one year
  • Already included into another clinical study competing with the objectives of the CAN-SAVE R study
  • <18 years old

Treatment and study plan

Pacing mode

Device

To determine which mode (DDD vs AAI SafeR)minimizes ventricular pacing

Primary outcomes

  1. to evaluate the effectiveness of SafeR

    Time frame: 1 and 3 years

  2. preserve natural AV conduction compared to DDD Long AVD

    Time frame: 1 and 3 years

  3. demonstrate the effectiveness of SafeR to reduce AF incidence on a LT basis

    Time frame: 1 and 3 years

  4. compare the effects of SafeR vs DDD Long AVD on LV function

    Time frame: 1 and 3 years

Secondary outcomes

  1. total mortality

    Time frame: 1 and 3 years

  2. CHF-related mortality & hospitalisations

    Time frame: 1 and 3 years

  3. evolution of systemic BP

    Time frame: 1 and 3 years

  4. AF-related AEs

    Time frame: 1 and 3 years

  5. evolution of cardiac asynchrony [interventricular (RV-LV) & intraventricular (4 segments)

    Time frame: 1 and 3 years

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • Sorin Group Canada

Registry information

Official study title

A Prospective Canadian Multi-center Randomized Study of the Benefits of Spontaneous Atrioventricular Conduction (Can Save R)

Acronym: CAN-SAVER

Important dates

Study start
2006
Primary completion
2012
Study completion
2013
First posted
Nov 18, 2009
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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